Ibl C1Q-CIC Cia Test
FDA 510(k) K032254 · Ibl GmbH
510(k) numberK032254
Submission
- Device name
- Ibl C1Q-CIC Cia Test
- Applicant
- Ibl GmbH
East Stroudsburg, PA, US - Received
- July 22, 2003
- Decision date
- August 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAK – Complement C1q, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code DAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031563 | Bindazyme CLQ Cic Eia KitDAK · Traditional | The Binding Site, Ltd. | 09/10/2003SE |
| K012576 | CIC-C1Q EiaDAK · Traditional | American Laboratory Products Co., Ltd. | 01/29/2002SE |
| K973203 | Thymostat Elisa for the Detection of Human Igg,M and a Anti-Rabbit Igg AntibodiesDAK · Traditional | Sangstat Medical Corp. | 09/30/1998SE |
| K972873 | Immustrip Hama IggDAK · Traditional | Immunomedics, Inc. | 03/17/1998SE |
| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| K914388 | C1 Rid KitDAK · Traditional | The Binding Site, Ltd. | 10/28/1991SE |
| K882829 | Circulating Immune Complexes ControlsDAK · Traditional | Cytotech, Inc. | 08/04/1988SE |
| K860996 | Sanassay Ic TestDAK · Traditional | Scientific Sales Intl., Inc. | 03/30/1987SE |
| K864312 | Ic MicroassayDAK · Traditional | Diamedix Corp. | 01/09/1987SE |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | Cytotech, Inc. | 09/04/1986SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K051969 | Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin)…CHQ · Traditional | 10/03/2005SE |
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | 09/24/2004SE |
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | 07/22/2004SE |
| K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and SalivaJIT · Traditional | 02/27/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | 01/13/2004SE |
Questions and answers
When was Ibl C1Q-CIC Cia Test cleared by the FDA?
Ibl C1Q-CIC Cia Test (K032254) received a 510(k) decision of Substantially Equivalent on August 29, 2003, 38 days after the submission was received.
What is the product code of K032254?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.